NCT00703287已完成不适用
Randomized Trial of a Specialized Physiotherapy Program Versus Standard Physiotherapy Advice in Patients With Cervical Dystonia (Spasmodic Torticollis).
Dr Donald Grosset2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- To compare different types of physiotherapy for treating condition
研究概览
简要总结
The investigators wish to establish on a small scale the effectiveness of adding the physiotherapy programme developed by Jean-Pierre Bleton to the present standard treatment for cervical dystonia with a view to undertaking a larger UK-wide trial looking at overall cost-effectiveness. Specifically, the investigators wish to establish:
- Whether this specific physiotherapy program for cervical dystonia improves patient outcomes in terms of neck position, pain, disability, and quality of life compared to simple physiotherapy advice?
- What is the minimal clinically important change in the new CDIP-58 quality of life measure for cervical dystonia from a patient's perspective that could then be used to plan a definitive trial of this technique?
- What are the economic implications of the specialized physiotherapy programme?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the following inclusion criteria must be met:
- •Any person over 16 years with primary cervical dystonia causing sufficient interference in lifestyle that they wish to consider physiotherapy treatment and who is able to give informed consent.
- •An abnormal neck position (Toronto Western Spasmodic Torticollis Rating Scale [TWSTR] Part 1A > 0).
- •Patients receiving treatment with botulinum toxin (type A or B) injections (as most will) provided they are on a stable botulinum toxin regimen (i.e. same dose and injection pattern over the previous two injections). This includes those newly diagnosed patients who choose to have botulinum toxin injections OR patients not receiving botulinum toxin (either because of patient preference or previous lack of effect) provided they plan to remain off botulinum toxin for the one year duration of the trial. There will probably be few of these patients but we feel justified in including them because there are no other treatments on offer and because it is presently unknown whether physiotherapy requires botulinum toxin to weaken the muscles in order to have an effect. Anecdotal reports suggest that it can be effective even without botulinum toxin. However, the small numbers who are not receiving botulinum toxin will be analysed as a separate subgroup initially to check whether their response is significantly different to those receiving botulinum toxin.
排除标准
- •Patients with any of the following criteria will be excluded:
- •Secondary cervical dystonia (e.g. acute onset following trauma or secondary to drugs)
- •A fixed cervical dystonia which may imply a psychogenic component.
- •Radicular or myelopathic features where cervical manipulation may be dangerous.
- •Patients known to have fused cervical vertebrae from previous x-rays
- •Previous use of the Bleton technique.
- •Deep brain stimulation for cervical dystonia.
- •Unable to comply with visits for physiotherapy and assessment.
结局指标
主要结局
To compare different types of physiotherapy for treating condition
时间窗: Review at 1 month, 3 months & 12 months
次要结局
未报告次要终点
研究者
Dr Donald Grosset
Consultant Neurologist
South Glasgow University Hospitals NHS Trust
研究点 (2)
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